Spots Global Cancer Trial Database for Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas

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Trial Identification

Brief Title: Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas

Official Title: A Phase II Trial of Combination Therapy With Thalidomide and CPT-11 in Patients With Recurrent Anaplastic Gliomas or Glioblastoma Multiforme

Study ID: NCT00412542

Conditions

Glioblastoma Multiforme

Glioma

Interventions

Thalidomide

CPT-11

MRI Scan

Quantitative Sensory Tests (QST)

Study Description

Brief Summary: Objectives: 1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas. 1.2 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11. 1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas. 1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker for treatment effect.

Detailed Description: Thalidomide is a drug that interferes with the growth of blood vessels. Thalidomide may help to decrease the blood supply in the tumor and make it unable to grow. CPT-11 is a drug that was designed to stop cancer cells from dividing. All participants will take thalidomide capsules by mouth every evening at bedtime. You will begin with 1 capsule every night for the first week then increase to 2 capsules every night for a week and then 3 capsules a night for the third week. After that, you will increase the dose to 4 capsules each night for the rest of the study. The dosages may be adjusted if you experience any severe side effects. In addition to thalidomide, you will receive treatment with CPT-11 through a continuous injection into a vein over 90 minutes once a week for 4 weeks followed by 2 weeks of rest from the drug. This 6 week period is called a course of therapy. The courses of therapy will be repeated as long as the disease is responding to treatment for up to 2 years. THIS IS AN INVESTIGATIONAL STUDY. Both drugs are commercially available. Thalidomide and CPT-11 are FDA approved for the treatment of some cancers. The combination of these drugs is investigational. Up to 78 participants will take part in this study. All will be enrolled at M. D. Anderson.